Submission Details
| 510(k) Number | K072107 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 31, 2007 |
| Decision Date | February 14, 2008 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
K072107 - PERIOSCAN, MODEL: D 3496
(FDA 510(k) Clearance)
Feb 2008
Decision
198d
Days
Class 2
Risk
K072107 is an FDA 510(k) clearance for the PERIOSCAN, MODEL: D 3496, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on February 14, 2008, 198 days after receiving the submission on July 31, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.
Device Classification
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4850 |
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